Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00782405
First received: October 24, 2008
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to examine the effects of (a) quetiapine XR and (b) mirtazapine on sleep when given as an antidepressant (monotherapy). We hypothesize that (a) quetiapine XR has an immediate and lasting positive effect on sleep in depressed patients which does not differ from the impact of mirtazapine on sleep in this group of patients; (b) in the context of a secondary objective, we expect an antidepressant effect of quetiapine XR which is equivalent to that of mirtazapine.


Condition Intervention Phase
Sleep
Drug: quetiapine
Drug: mirtazapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • sleep effiency [ Time Frame: n.a. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2008
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
quetiapine
Drug: quetiapine
XR, 150-300mg
Active Comparator: 2
mirtazapine
Drug: mirtazapine
30-45 mg

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of written informed consent
  2. A diagnosis of Major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, revised (DSM-IV-R)
  3. Clinically significant sleep disturbance (PSQI total score > 5)
  4. Females and males aged 18 to 65 years
  5. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
  6. Able to understand and comply with the requirements of the study
  7. Minimum score in the HAMD-21 scale: 18

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Any DSM-IV-R Axis I disorder not defined in the inclusion criteria
  3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  4. Known intolerance or lack of response to quetiapine fumarate and / or mirtazapine, as judged by the investigator
  5. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
  6. Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampicin, St. John's Wort, and glucocorticoids
  7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
  8. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV-R criteria
  9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV-R criteria within 4 weeks prior to enrolment
  10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
  11. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
  12. Involvement in the planning and conduct of the study
  13. Previous enrolment or randomisation of treatment in the present study.
  14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
  15. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:

    • Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%.
    • Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
    • Not under physician care for DM
    • Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
    • Physician responsible for patient's DM care has not approved patient's participation in the study
    • Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks.
    • Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
  16. An absolute neutrophil count (ANC) of ≤ 1.5 x 109 per liter
  17. Respiratory distress index during the 1st polysomnography > 10
  18. Periodic leg movement / arousal index during the 1st polysomnography > 10
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782405

Locations
Germany
Sleep Disorders Center
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Michael H Wiegand, Prof. Sleep Disorders Center
  More Information

No publications provided

Responsible Party: Technical University of Munich, TechnischeUM
ClinicalTrials.gov Identifier: NCT00782405     History of Changes
Other Study ID Numbers: D114432C00027
Study First Received: October 24, 2008
Last Updated: April 18, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
antidepressant action
clinical psychopharmacology

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Mirtazapine
Mianserin
Quetiapine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 29, 2014